Agreement with FDA would allow Triad to resume production

By Rick Barrett of the Journal Sentinel

Published on: 6/10/2011

A Hartland medical products company, which ceased manufacturing in early April after regulators found flaws in its products and procedures, would be able to resume production if it follows strict guidelines and allows intense scrutiny, according to a court document filed Friday.

The consent agreement in U.S. District Court in Milwaukee would impose fines of $15,000 per day and per violation if Triad Group Inc. failed to comply with the policies set by the U.S. Food and Drug Administration.

According to the agreement, the company would have to hire a consultant to inspect the manufacturing plant as well as the methods and controls used to make products. And it would have to reimburse the FDA for the cost of inspections, investigations, supervision and more - including $104.96 per hour per person for analytical or review work.

Triad is one of the nation's largest manufacturers of antiseptic pads and other products used in hospitals and sold in drugstores such as Walgreens and CVS. As of last fall, Triad had about 350 employees at its Hartland facility. The family-owned company has been in business since 1976.

Consumer lawsuits have alleged that Triad products caused the death of a child in Texas and injuries to people in Colorado and Tennessee.

A lawsuit by a Texas couple blames a Triad product for the death of their 2-year-old son. In that lawsuit, filed in federal court in Houston, Shanoop and Sandra Kothari say an alcohol wipe made by the company was the likely source of a bacterial infection that killed their son, Harry, on Dec. 1.

A month after his death, the FDA posted a notice saying Triad was issuing an urgent recall of all lots of its alcohol swabs and wipes because the products might have been contaminated with the bacteria Bacillus cereus.

The FDA was aware of problems with manufacturing sterility and contamination at the company's plant - yet little was done to protect the public until the recalls were launched in December and earlier this year, according to a Journal Sentinel investigation.

The FDA now says it should have issued a warning letter to Triad in 2010.

The written notice would have reinforced the agency's concerns, said Jeanne Ireland, the FDA's assistant commissioner for legislation, in a letter sent Thursday to U.S. Sens. Michael Bennet (D-Colo.) and Lamar Alexander (R-Tenn.), who have pressed the agency about its handling of Triad.

The problems at Triad are a reminder that the supply chain for drugs and medical devices needs to be fixed, Bennet said.

"The last thing families in Colorado and across the country should have to worry about is that the treatments they use may do them harm, or potentially worse," he said.

Triad has denied any responsibility for the death of the child in Texas or for illnesses from its products.

The FDA hasn't made that connection, either. Yet its inspection reports have revealed numerous regulatory violations at the company's H&P Industries manufacturing plant in Hartland, and contaminated products.

Triad declined to comment Friday on the FDA's letter or the consent decree.

Cost in the millions

Over five years, the consent decree could cost Triad millions of dollars - and there's no guarantee the company would be able to meet the requirements that would cover virtually every aspect of its manufacturing process.

"Companies can successfully emerge from a consent decree, but it's a long haul," sometimes longer than five years, said Mark Kramer, an FDA regulatory consultant in Fox Point.

Triad has agreed to the consent decree, according to the FDA, but the decree won't be official until it's signed by the company's owners, the FDA and court officials, among others.

Without the decree, the company would not be allowed to manufacture or distribute its products.

"They have to establish an acceptable quality assurance and quality control program," said FDA spokeswoman Shelly Burgess.

Among many other things, the consent decree would subject the company to FDA inspections without prior notice. Those inspections could cover everything from equipment and raw materials to finished products and packaging materials. The company also would have to post a $4 million bond.

It can take months for a company to meet the terms of an FDA consent decree before it resumes production, Kramer said.

Triad, through its manufacturer H&P Industries, has a history of regulatory violations including producing moldy cosmetic wipes and unsterile medical lubrication jelly, according to FDA inspection records.

Still, the FDA allowed the company to continue to operate even as inspectors found violations. Rather than issue a warning letter, it gave verbal warnings and repeatedly accepted the company's promises to correct problems.

Of the FDA's admission that it should have issued a warning letter, Bennet said: "It appears that in this case the FDA has provided an honest assessment in recognizing that stronger actions should have been taken earlier to prevent this incident from occurring. It is imperative that the FDA take appropriate action in the future to avoid a repeat of this unfortunate incident."